Nifedipine sustained release tablets and preparation process thereof

Abstract

The invention discloses nifedipine sustained release tablets and a preparation process thereof. The nifedipine sustained release tablets are prepared from nifedipine, a sustained release agent, a bulking agent, a bonding agent, a solubilizer and a lubricant by the steps of pulverizing, sieving, mixing, granulating, drying, tabletting and film coating. The sustained release agent adopts chitosan, and weight percentages of the components are as follows: nifedipine 20%, chitosan 14-24%, bulking agent 50-60%, bonding agent 4%, solubilizer 1%, and lubricant 1%. The nifedipine sustained release tablets of the invention are simple in production process and long in sustained release action, the adverse reactions after administration are less and mild, and the curative effect on mild and moderate hypertension is definite. The nifedipine sustained release tablets can uniformly release nifedipine within 24 hours, can last the effective blood concentration over 24 hours, and only need to be administered once everyday.

Description

technical field [0001] The invention relates to the field of drug sustained-release preparations, in particular to a nifedipine sustained-release tablet and a preparation process thereof. Background technique [0002] Nifedipine is one of the calcium antagonists. It is a blood pressure lowering drug. It has a strong effect of dilating coronary arteries and peripheral arteries, and has a significant effect of inhibiting vasospasm. Due to the short half-life of nifedipine ordinary tablets (about 2.0 hours) and short maintenance time, patients need to take the medicine multiple times (3 to 4 times a day) to achieve the purpose of lowering blood pressure. Because the release rate of common nifedipine preparations is not stable, the blood drug concentration in the human body fluctuates greatly, and side effects such as dizziness, flushing and heart palpitations are likely to occur. The human body releases it slowly and evenly at a certain speed, so that the drug effect is mo...

AI Technical Summary

Problems solved by technology

However, the existing nifedipine sustained-release tablets still have unsatisfactory parts such as short duration of action (generally 12 hours, taking 2 times a day), often accompanied by adverse reactions; Dipine controlled-release tablets, although their drug release stability is better than sustained-release tablets, and only need to be taken once a day, all need to adopt laser pore-forming osmotic pump type controlled release technology, which has complicated preparation process, high manufacturing cost, and high yield. Insufficient

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